两种不同剂量辛伐他汀对冠心病患者血脂异常的疗效与安全性评价
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Lipid-Regulating Efficacy and Safety by Different Doses of Simvastatin in Patients with Coronary Heart Disease
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    探讨两种剂量辛伐他汀治疗冠心病血脂异常患者的疗效与安全性。采用自身对照的方法,选取总胆固醇≥4.68 mmol/L和/或低密度脂蛋白胆固醇≥26mmol/L的冠心病患者,按随机原则分别入选辛伐他汀10mg剂量组与20 m剂量组,10mg组52例,其中男性34例,女18例,平均年龄67.9岁;20 mg组50例,男31例,女19例,平均年龄67.2岁。于服药后90 d和180 d后复查血脂、肝肾功能和肌酸激酶,并记录随访期间不良反应。结果发现,辛伐他汀10mg组与20mg组分别在90和180 d后总胆固醇和低密度脂蛋白胆固醇水平较治疗前均显著降低(p<0.05)。20 mg组在90和180 d后总胆固醇和低密度脂蛋白胆固醇降低的幅度较10 mg组均有显著性增高(p<0.05)。10 mg和20 mg组在治疗180 d后降低总胆固醇的达标率分别为23%和34%;降低低密度脂蛋白胆固醇的达标率分别为25%和44%,组间有显著性差异(p<0.05)。在随访期间高密度脂蛋白胆固醇有逐渐升高;甘油三酯呈逐渐降低的趋势,但无统计学上的显著性意义。治疗期间有少数患者肝酶和肌酸激酶轻度升高,无严重不良反应。此结果提示,辛伐他汀每日10mg或20mg均能有效降低冠心病血脂异常患者总胆固醇及低密度脂蛋白胆固醇水平而且安全,20 mg剂量组的效果优于10 mg组。

    Abstract:

    Aim To investigate the efficacy and Safety of simvastatin on patients with coronary heart disease.Methods The study was a random,open,two-dose control trail to evaluate simvastatin administering (10,20 mg/d) to 102 patients with myocardial infarction or angina, whose total cholesterol (TC) was over 2.68 mmol/L and low density lipoprotein cholesterol (LDLC) was over 2.6 mmol/L. Lipid level was determined after 90 and 180 d. Results The blood concentrations of TC and LDLC were significantly decrease after treating withlO and 20 mg simvastatin 90 d and 180 d (P< 0.05)and the curative effect of 20 mg group was more evident than that of 10 mg group (P< 0.05). The TC target rates of 10 mg and 20 mg after 180 d were 21% and 40% and the LDLC target rates of 10 mg and 20 mg after 180 d were 25% and 44% ( P< 0.05). The level of high density lipoprotein cholesterol was gradually increased; the triglyceride was decreased during the following-up, but there were no significant different. The adverse reaction of simvastatin was mild and relatively rate. Conclusion The results suggested that 10 mg or 20 mg of simvastatin could markedly decrease TC and LDLC concentration and was safety and feasible; the effect of 20 mg-group is superior to 10 mg-group.

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肖观莲,梁燕琼,彭若宇.两种不同剂量辛伐他汀对冠心病患者血脂异常的疗效与安全性评价[J].中国动脉硬化杂志,2003,11(7):643~625.

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  • 收稿日期:2003-06-09
  • 最后修改日期:2003-12-20
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